The Patient Protection and Affordable Care Act (aka the health reform law) added “patient engagement” and “patient-centeredness” to the United States Code’s lexicon. Yesterday, the Centers for Medicare and Medicaid Services finalized the official definition of these terms for purposes of Accountable Care Organizations that may seek to participate in the Medicare Shared Savings Program. There are about 700 pages of regulations released by CMS yesterday, and there are tax, antitrust, and fraud and abuse rules and regs accompanying the ACO regs that were also finalized yesterday, so you’ll forgive me for not providing a tidy summary and analysis. Please feel free to peruse the CMS presser and links to the ACO resources (via my home blog, HealthBlawg).

So here are the unvarnished definitions (please note that “patient engagement” is defined as an element of “patient-centeredness”):

42 CFR §425.112 Required processes and patient-centeredness criteria.

(a) General. (1) An ACO must —
(i) Promote evidence-based medicine and beneficiary engagement, internally report on
quality and cost metrics, and coordinate care;
(ii) Adopt a focus on patient centeredness that is promoted by the governing body and
integrated into practice by leadership and management working with the organization’s health
care teams; and
(iii) Have defined processes to fulfill these requirements.
(2) An ACO must have a qualified healthcare professional responsible for the ACO’s
quality assurance and improvement program, which must include the defined processes included
in paragraphs (b)(1) through (4) of this section.
(3) For each process specified in paragraphs (b)(1) through (4) of this section, the ACO
must —
(i) Explain how it will require ACO participants and ACO providers/suppliers to comply
with and implement each process (and subelement thereof), including the remedial processes and
penalties (including the potential for expulsion) applicable to ACO participants and ACO
providers/suppliers for failure to comply with and implement the required process; and
(ii) Explain how it will employ its internal assessments of cost and quality of care to
improve continuously the ACO’s care practices.
(b) Required processes. The ACO must define, establish, implement, evaluate, and
periodically update processes to accomplish the following:
(1) Promote evidence-based medicine. These processes must cover diagnoses with
significant potential for the ACO to achieve quality improvements taking into account the
circumstances of individual beneficiaries.
(2) Promote patient engagement. These processes must address the following areas:
(i) Compliance with patient experience of care survey requirements in §425.500.
(ii) Compliance with beneficiary representative requirements in §425.106.
(iii) A process for evaluating the health needs of the ACO’s population, including
consideration of diversity in its patient populations, and a plan to address the needs of its
population.
(A) In its plan to address the needs of its population, the ACO must describe how it
intends to partner with community stakeholders to improve the health of its population.
(B) An ACO that has a stakeholder organization serving on its governing body will be
deemed to have satisfied the requirement to partner with community stakeholders.
(iv) Communication of clinical knowledge/evidence-based medicine to beneficiaries in a
way that is understandable to them.
(v) Beneficiary engagement and shared decision-making that takes into account the
beneficiaries’ unique needs, preferences, values, and priorities;
(vi) Written standards in place for beneficiary access and communication, and a process
in place for beneficiaries to access their medical record.
(3) Develop an infrastructure for its ACO participants and ACO providers/suppliers to
internally report on quality and cost metrics that enables the ACO to monitor, provide feedback,
and evaluate its ACO participants and ACO provider(s)/supplier(s) performance and to use these
results to improve care over time.
(4) Coordinate care across and among primary care physicians, specialists, and acute and
post-acute providers and suppliers. The ACO must–
(i) Define its methods and processes established to coordinate care throughout an episode of
care and during its transitions, such as discharge from a hospital or transfer of care from a
primary care physician to a specialist (both inside and outside the ACO); and
(ii) As part of its application, the ACO must:
(A) Submit a description of its individualized care program, along with a sample individual
care plan, and explain how this program is used to promote improved outcomes for, at a
minimum, its high-risk and multiple chronic condition patients.
(B) Describe additional target populations that would benefit from individualized care plans.

Yes, the language is sort of impenetrable. Humans at CMS are charged with determining what it really means. I’d like to see if some of the other humans reading this have some thoughts about how the federales did with these definitions: Are you satisfied that these definitions will ensure that accountable care organizations will be patient-centered, and will be patient engagement machines? Are there any issues that CMS needs to be aware of as it reviews applications from organizations seeking recognition as ACOs? Please join the conversation in the comments.

David Harlow is a health care lawyer and consultant at The Harlow Group LLC, and chairs the Society for Participatory Medicine’s public policy committee. You should follow him on Twitter: @healthblawg.

Comments

Given the assumption that the healthcare practitioner is spot on in his recommendations to the patient and his use of healthcare dollars, this model of patient engagement presumes that the patient wants to be engaged and that 1) the patient believes and understands what the physician is saying even if layspeak is employed, and 2) there are no ulterior motives, no secondary gain (monetary or otherwise) by either passive or active means to embracing the sick role. This push for accountability on the part of providers will not work unless patients (and that includes all of us) accept responsiblity for their actions.

Among the 1300 comments filed in response to the draft ACO regulations, there are provider comments which essentially asked to not be held responsible for costs associated with caring for “unmanageable” patients. Here’s an excerpt from the government response:

“Beneficiaries who choose to receive care from ACO
providers, regardless of whether they are ‘unmanageable’ or noncompliant with treatment recommendations may become part of the ACO’s assigned population. Since patient-centeredness is an integral part of this program, we believe such beneficiaries represent an
excellent opportunity for ACOs to create, implement, and improve upon patient-centered
processes that improve patient engagement.”

So the government is explicitly leaving this monkey on providers’ backs.

The government is not explicit in acknowledging that not every patient wants to be engaged. This was the subject of one of a hallway conversation at a conference I was at last week, and I believe it is important to acknowledge patients who do not want to be engaged, and to respect this wish (as health care providers are trained to respect other patient wishes even if they are not consonant with providers’ personal beliefs, or opinions about what would be best for the patient).

The regs are deliberately non-prescriptive. I’d be interested in hearing what folks think would be reasonable approaches for health care provider organizations to take in addressing these issues (i.e., managing unmanageable patients and patients who do not wish to be engaged).

All this makes me shiver with fear. As a person with a rare chronic health condition, the last place I would want to be treated is in an ACO. My understanding is that they are paid on outcomes, not procedures, which is all well and good, as long as your patient population has easily managed conditions. It is the old fashioned capitation system pure and simple. Sick people like me would not be welcome.

As we peel back the layers of this monster piece of legislation, we find more and more how issues like this are impossible to monitor for compliance. We will end up with are thousands of pages of top down gobbildy gook. Our doctors will opt out of all of this madness and patients care will suffer.

Patient centeredness is not created by law, it is created between two people.

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Participatory Medicine is a model of cooperative health care that seeks to achieve active involvement by patients, professionals, caregivers, and others across the continuum of care on all issues related to an individual's health. Participatory medicine is an ethical approach to care that also holds promise to improve outcomes, reduce medical errors, increase patient satisfaction and improve the cost of care.